UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045956 |
|---|---|
| Receipt number | R000052454 |
| Scientific Title | Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2022/03/11 11:31:57 |
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Basic information
Public title
Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Acronym
Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Scientific Title
Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Scientific Title:Acronym
Effect of the test food consumption on Saliva Production: A Randomized, Placebo-Controlled, Double-Blind, Crossover Study
Region
| Japan |
Condition
Condition
Healthy Japanese subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the increase in saliva production by ingesting the test food.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of change in saliva secretion after two weeks of start intake of the test food from screening test.
Key secondary outcomes
1. Amount of change in saliva secretion after one week of start intake of the test food from screening test.
2. Measured amount of saliva secretion after one week of start intake of the test food.
3. Measured amount of saliva secretion after two weeks of start intake of the test food.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Period I: Active hard capsule
Period II: Placebo
Administration:
<Period I, Period II>Take 1 capsule once a day after breakfast.
*The intervention sequence is Period I to Period II, and each food is single ingestion.
Interventions/Control_2
Period I: Placebo
Period II: Active hard capsule
Administration:
<Period I, Period II>Take 1 capsule once a day after breakfast.
*The intervention sequence is Period I to Period II, and each food is single ingestion.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. In-house employees
2. Healthy subjects who lack the moisture of the mouth
3. Subjects with low saliva volume at screening
Key exclusion criteria
1. Subjects with low saliva production at screening test (< 2 g by Saxon test)
2. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction.
3. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD).
4. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases.
5. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily.
6. Subjects who are currently taking medications (including herbal medicines) and supplements.
7. Subjects who are allergic to medicines and/or the test food related products.
8. Subjects who are pregnant, lactation, or planning to become pregnant.
9. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to enroll in another clinical trial during trial period.
10. Subjects who have history of respiratory disease or current illness.
11. Subjects with autoimmune disease.
12. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Goto |
Organization
Medical corporation Seiryukai group the Goto Clinic
Division name
Director
Zip code
493-0005
Address
170 Kisogawa-cho Satokomakinokata, Ichinomiya-shi, Aichi-ken, Japan
TEL
0586-87-7800
info@oryza.co.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Yamauchi |
Organization
Oryza Oil & Fat Chemical Co. Ltd
Division name
Manufacturing Technology Department
Zip code
493-8001
Address
1 Kitagata-cho Numata, Ichinomiya-shi, Aichi-ken, Japan
TEL
0586-86-5141
Homepage URL
seigi@oryza.co.jp
Sponsor or person
Institute
Oryza Oil & Fat Chemical Co. Ltd
Institute
Department
Personal name
Funding Source
Organization
Oryza Oil & Fat Chemical Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel
03-5793-3623
IRB@takara-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
オリザ油化株式会社 (愛知県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 02 | Day |
Last modified on
| 2022 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052454
